Clinical DeteriorationCOCOMONCT04189653
Clinical Outcomes After Implementation of COntinuous Vital Sign Monitoring On the General Ward.
An observational study of Clinical Deterioration, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Deterioration
- What is being tested?
- Continuous Monitoring
- How many people
- 3,896 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2018to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult general ward patients of the GE-surgery and Internal Medicine wards of a Dutch tertiary academic hospital.
Who may be able to join
- Admission on Inclusion ward.
Who cannot join
- Opt out of file study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes After Implementation of Continuous Vital Sign Monitoring on the General Ward.
In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital. Rather than taking the measurements manually, this enabled the nurses to periodically validate the continuously derived vital signs at the protocolled moments, and simultaneously get an automatically calculated MEWS reading,. Moreover, continuous vital sign monitoring provides single channel alarms and trends of the vital signs in between the regular measurement moments. Compared to periodic manual measurements and registration in the EMR, the continuous vital sign monitoring and automated MEWS calculations in the EMR may result in better identification of clinical deterioration, and may improve clinical outcome.
The primary objective of this study is to evaluate changes in total hospital and ward stay, "Total Events" during admission (rapid response team (RRT) calls and unexpected intensive care unit (uICU) admissions and deaths) after implementation of CM on the regular surgical and internal medicine wards. Secondary objective is to evaluate changes in MEWS scores at the moment of the uICU admissions, length of hospital, ward and ICU stay and the proportion of RRT calls that results in a ICU admission.
- Conditions
- Clinical Deterioration
- Being tested
- Continuous Monitoring
- Keywords
- Early Warning Scores, Continuous Vital Sign Monitoring, Escalation of Care, ICU-Transfer, Deterioration prevention
- Medical subject headings
- Clinical Deterioration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous MonitoringOther
Wireless continuous vital sign monitoring (HR, RR, SBP/DBP, SAT)
| Study group | Role | What they receive |
|---|---|---|
| General Ward Inpatients 2017-2018 | ALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2017-august 31st 2018. | |
| General Ward Inpatients 2018-2019 | ALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2018-august 31st 2019. Receives: Other: Continuous Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unexpected Intensive Care Unit Admissions
Unexpected Intensive Care Unit Admissions
Measured: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Rapid Response Team Activations
Rapid Response Team Activations
Measured: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Secondary outcomes (1)
Length of Stay
Length of stay on the ward, ICU and Hospital stay as whole
Measured: During ward, ICU and hospital admission, till discharge, transfer to other hospital or death. Average of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical DeteriorationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189653
- Sponsor's protocol ID
- 2018-4330
- Acronym
- COCOMO
- Status last verified
- Nov 2019
- First submitted
- 4 Dec 2019
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes After Implementation of Continuous Vital Sign Monitoring on the General Ward.
- ClinicalTrials.gov ID
- NCT04189653
- Acronym / sponsor ID
- COCOMO / 2018-4330
- Conditions
- Clinical Deterioration
- Keywords
- Early Warning Scores, Continuous Vital Sign Monitoring, Escalation of Care, ICU-Transfer, Deterioration prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,896 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2018, continuous monitoring (CM) of 5 vital signs with a wearable device, including automated MEWS calculation within the EMR were introduced on the surgical and internal medicine ward of our hospital. Rather than taking the measurements manually, this enabled the nurses to periodically validate the continuously derived vital signs at the protocolled moments, and simultaneously get an automatically calculated MEWS reading,. Moreover, continuous vital sign monitoring provides single channel alarms and trends of the vital signs in between the regular measurement moments. Compared to periodic manual measurements and registration in the EMR, the continuous vital sign monitoring and automated MEWS calculations in the EMR may result in better identification of clinical deterioration, and may improve clinical outcome.
The primary objective of this study is to evaluate changes in total hospital and ward stay, "Total Events" during admission (rapid response team (RRT) calls and unexpected intensive care unit (uICU) admissions and deaths) after implementation of CM on the regular surgical and internal medicine wards. Secondary objective is to evaluate changes in MEWS scores at the moment of the uICU admissions, length of hospital, ward and ICU stay and the proportion of RRT calls that results in a ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Ward Inpatients 2017-2018 | – | –ALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2017-august 31st 2018. |
| General Ward Inpatients 2018-2019 | – | Other: Continuous MonitoringALL General Ward Inpatients on our Gastro-Enterology Surgery ward and Internal Medicine ward in the period august 1st 2018-august 31st 2019. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult general ward patients of the GE-surgery and Internal Medicine wards of a Dutch tertiary academic hospital.
Key inclusion criteria (1 listed)
- Admission on Inclusion ward.
Key exclusion criteria (1 listed)
- Opt out of file study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous MonitoringWireless continuous vital sign monitoring (HR, RR, SBP/DBP, SAT) | Other | General Ward Inpatients 2018-2019 |
Primary outcome
Unexpected Intensive Care Unit Admissions
Time frame: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Unexpected Intensive Care Unit Admissions
Rapid Response Team Activations
Time frame: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.
Rapid Response Team Activations
1 secondary outcome
Length of Stay
Time frame: During ward, ICU and hospital admission, till discharge, transfer to other hospital or death. Average of 5 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Deterioration, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unexpected Intensive Care Unit Admissions (time frame: During ward admission, from moment of arival on ward till discharge or transfer, average of 4 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.